A federal judge last week granted cancer biologist and biochemist Philippe Bois, who was charged with scientific misconduct in 2011, a hearing to defend himself against the charges.

If the ruling goes uncontested by the Office of Research Integrity (ORI) and the Department of Health and Human Services (HHS), Bois will be the first researcher granted such a hearing since ORI instated stricter misconduct regulations in September 2005.

"We argued, and the federal agreed, that the [HHS administrative law judge]"—who dished out the ruling of misconduct last May—"acted unreasonably and violated the law when she denied Dr. Bois a hearing and deprived him of the chance to prove any mistakes were unintentional errors," said Bois’s lawyer, Richard Goldstein of the law firm Donoghue, Barrett & Singal, PC.

On May 16, 2011, the ORI found that Bois committed two counts of research misconduct while working as a postdoc at St. Jude Children's Research Hospital. The agency submitted that he falsified an image to conceal undesired results in research published in the Journal of Cell Biology, which was later retracted, and purposefully mislabeled gel lanes in a Molecular and Cellular Biology paper.

After the ORI issues a charge letter, the accused researcher has 30 days to respond to each point in detail and request a hearing to further defend him or herself against the allegations before an administrative law judge (ALJ). Bois requested a hearing in the allotted time, but the ORI moved to dismiss the request on the grounds that he raised no new factual evidence to contradict the charges. After reviewing the case, an ALJ from the HHS Departmental Appeals Board agreed with the ORI, officially debarring Bois from federal research funding for 3 years.

But Bois appealed the hearing to federal court, arguing that the so-called falsifications were, in fact, merely honest mistakes. On the first count, he claimed that he “forgot” about conducting the initial experiment that contradicted the findings he published and, thus, it was not purposeful deceit.

On the second count, he held that the court ignored testimony from the postdoc who conducted the experiment in question. According to Bois’s account, he took instruction from the postdoc when labeling the figures and thus he was unaware of the falsification.

District Court Judge Amy Berman Jackson reconsidered the case upon his appeal and last Friday (March 2) submitted her opinion. She upheld ORI’s findings for misconduct on the first count because Bois did not submit any new “admissible” factual evidence, and agreed with the ALJ that “his failure to review his lab notebooks before reporting the results of the [experiment] was sufficient to support a finding of reckless research misconduct on its own” (emphasis original).

But on the second count, Judge Jackson held that Bois deserved a hearing—not because his factual evidence was particularly compelling, she emphasized, but because the ALJ failed to respond to his argument thoroughly.

“Dr. Bois’s story lacks coherence, and he provided little that would enable the ALJ to find it to be particularly plausible or persuasive,” the opinion reads. “But the ALJ was required to at least acknowledge his version and explain her reasons for rejecting it. And it is here that the ALJ stumbled.”

This reasoning does not bode well for Bois’s chances of being cleared of charges, which remains in the hands of the original ALJ, said George Annas, the head of health law and bioethics at Boston University. “It’s hard to believe any of those [explanations] are going to influence the judge who heard the case in the first place,” he said. “Unless he has some information we don’t know about—new information to present to show that this wasn’t intentional—it seems unlikely he’s going to get a clean bill of health from this judge.”

And in either case, Bois’s first charge of misconduct was still upheld. “I don’t know how many times you have to be guilty of misconduct to be guilty of misconduct, but it seems like one would be fine,” added Annas.

Hear me out

ORI rarely entertains defense hearings. Since 2006, the agency has closed 153 cases of misconduct according to annual reports. Bois is the fifth researcher to request a hearing in that time, but none of the previous requests were ever heard: two were dismissed by ORI, and one was withdrawn by the researcher.

The fourth request was the closest ORI ever got to hosting a hearing in the last 5 years. Scott Brodie, a former AIDS researcher from the University of Washington was charged with 15 counts of misconduct in 2009. He requested a hearing, and the judge “held that Dr. Brodie raised triable issues about his intent to commit scientific misconduct,” as well as the reasonableness of 7-year disbarment period from federal funding.

But before a hearing took place, the ALJ submitted a recommendation to HHS upholding the original charges. Brodie appealed this decision and the lawsuits are still pending.

If Bois’s hearing is not similarly dodged, his hearing will be the first since ORI regulations changed in 2005.

HHS and ORI have no comment to make on the case at this time.

Regulating misconduct

The overhaul of ORI regulations in 2005, designed to streamline the misconduct procedure, was quite broad. The regulations clearly outlined the burden of proof required, the definition of misconduct, and gave the HHS Assistant Secretary for Health the opportunity to review decisions made by the ALJ.

The process to decide whether a hearing is warranted was also altered, with cases after 2005 decided by an ALJ instead of three scientist members of the Departmental Appeals Board.

“ORI changed its regulations in 2005 by eliminating the panel of scientists who adjudicated scientific misconduct cases and replacing it with a single ALJ, who is not a scientist but a practicing attorney,” Bois’s lawyers wrote in a press release. “Since that change, HHS ALJs have denied every single hearing request by a scientist accused of scientific misconduct.”

But whether the changes actually caused injustice to researchers is unclear. Hearing requests are very rare, said James Wells, director of the office of research policy at the University of Wisconsin, perhaps because ORI only goes after the gravest offenses.

“In general, ORI doesn’t have unlimited resources, so [the agency must] cherry pick what they get, and then maybe they go forward on one-third of those cases,” Wells said. “They seem to take the more serious cases and, in particular, those that have to do with fabrication and falsification.”

However, HHS and ORI still have the opportunity to further appeal the most recent decision to grant Bois a hearing. And, as Brodie’s case showed, there are other mechanisms to evade such costly and time-consuming legal proceedings.

Until then, the Judge Jackson ordered that Bois’s debarment from federal funding be lifted.

I would have thought giving people an opportunity to face their accusers and allowing them to defend themselves was a pretty basic standard in legal proceedings. Much though I loathe "scientists" who manipulate or falsify "data", I hate miscarriages of justice and witch-hunts even more.

I would have thought giving people an opportunity to face their accusers and allowing them to defend themselves was a pretty basic standard in legal proceedings. Much though I loathe "scientists" who manipulate or falsify "data", I hate miscarriages of justice and witch-hunts even more.

There are clear opportunities for hearings and appeals of ORI cases, and obviously these processes were used by the respondent in this case -- appeal of the Office of Research INtegrity (ORI) finding or administative action (debarment) to the HHS Departmental Appeals Board, and if denied by the Administrative Law Judge there, then to Federal Court.

If James Wells was quoted accurately by the newsreporter, myÂ opinion (from my 17 years as a senior ORI research fraud investigator, until 2006) isÂ different from his.Â ORI has pursued essentailly every serious and significant finding of research misconduct made by institutions against all levels of respondents (from full professors through technicians), and the few DAB hearings that have been requested were almost entirelyÂ by those whoÂ had beenÂ found by ORI to have committed theÂ "gravest offenses" -- massive falsification or fabrication ofÂ research, often involving numerous publications, grant applications, and other reports of research, frequentlyÂ covering manyÂ years.Â Â Â Â

There are clear opportunities for hearings and appeals of ORI cases, and obviously these processes were used by the respondent in this case -- appeal of the Office of Research INtegrity (ORI) finding or administative action (debarment) to the HHS Departmental Appeals Board, and if denied by the Administrative Law Judge there, then to Federal Court.

If James Wells was quoted accurately by the newsreporter, myÂ opinion (from my 17 years as a senior ORI research fraud investigator, until 2006) isÂ different from his.Â ORI has pursued essentailly every serious and significant finding of research misconduct made by institutions against all levels of respondents (from full professors through technicians), and the few DAB hearings that have been requested were almost entirelyÂ by those whoÂ had beenÂ found by ORI to have committed theÂ "gravest offenses" -- massive falsification or fabrication ofÂ research, often involving numerous publications, grant applications, and other reports of research, frequentlyÂ covering manyÂ years.Â Â Â Â

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